Status:

COMPLETED

Cardioventilatory Coupling in Critically Ill Patients

Lead Sponsor:

ASST Fatebenefratelli Sacco

Collaborating Sponsors:

Tommaso Fossali

Stefano Guzzetti

Conditions:

Critically Ill

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

This study measures the cardioventilatory coupling in critically ill patients during mechanical ventilation in controlled mode (pressure controlled) and in patient-driven mode (pressure support and ne...

Detailed Description

Intrathoracic pressure oscillations due to positive pressure ventilation induce cyclic modifications of activity of the pulmonary vascular receptors and cardiac mechanoceptors. These effects changes t...

Eligibility Criteria

Inclusion

  • patients consecutively admitted to the mixed intensive care unit of the Luigi Sacco Hospital with (all the following):
  • mechanical ventilation with an expected duration ≥ 48 hours
  • acute respiratory failure due to ALI/ARDS or COPD exacerbation or pneumonia or severe sepsis/septic shock
  • age between 18 and 75 years old

Exclusion

  • contraindications to esophageal tube positioning (i.e. esophageal varices, bleeding from upper enteric tract in the past 30 days)
  • history of esophageal or gastric or thoracic surgery
  • history of neuromuscular disease or stroke or head trauma
  • history of thyroidal or adrenal dysfunction
  • positive end expiratory pressure ≥ 10 cmH2O and/or inspiratory oxygen fraction ≥ 0.60, or intrinsic positive end expiratory pressure ≥ 8 cmH2O
  • needing for neuromuscular blocking drugs administration
  • patients unable to undergo to patient-driven mechanical ventilation mode (i.e. coma, excessive sedation)
  • mechanical circulatory support (i.e. intra-aortic balloon, extracorporeal membrane oxygenation)
  • norepinephrine ≥0.3 mcg/kg/min or epinephrine ≥0.05 mcg/kg/min or dobutamine ≥2.5 mcg/kg/min
  • non sinus cardiac rhythm or ectopic beats exceeding ≥5% of normal sinus beats
  • acute or chronic heart failure with reduced or preserved ejection fraction
  • recent acute miocardial infarct ≤6 months
  • recent recovery from respiratory failure or pneumonia or severe sepsis/septic shock ≤30 days
  • therapy with beta-blockers

Key Trial Info

Start Date :

September 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2017

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT02286869

Start Date

September 1 2016

End Date

July 1 2017

Last Update

August 1 2017

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Luigi Sacco Hospital

Milan, Italy, 20157

2

Istituto Clinico Humanitas

Rozzano, Italy, 20089